Study of the Link Between Complement Activation and IgA Nephropathy Severity

NCT ID: NCT05234463

Last Updated: 2025-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-09

Study Completion Date

2027-05-01

Brief Summary

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ICONE study (IgA Complement and NEphropathy is a prospective monocentric observational study.

The main objective is to evaluate the relevance of complement activation as a biomarker of disease severity and progression in patients with a biopsy proven IgAN.

Detailed Description

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IgA nephropathy (IgAN) is a common cause of glomerulonephritis and a major cause of end stage renal disease in up to 20-40% of patients. However, its prognosis still cannot be accurately predicted due to the high heterogenicity of clinical presentations and courses. Complement dysregulation is a main driver of glomerular damages in many glomerulonephritis. Given the growing body of evidence of complement lectin/alternative pathways activation in IgAN pathogenesis, the investigators propose the evaluation of a combination of biomarkers of infra-clinical complement activation to stratify the risk of disease's progression. This study aims to identify subsets of patients in whom complement activation plays a critical role in disease progression. This is of particular interest in the aera of emergence of complement-targeting therapies in IgAN

Conditions

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IgA Nephropathy Severity in Kidney Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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IgAN patients

Adult patients Histologically proven diagnosis of IgA nephropathy Primary and secondary forms of the disease With or without kidney transplantation history Regardless of kidney/graft function Patients followed in the Nephrology Department of Strasbourg University Hospital.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult patients, male or female, with a biopsy proven IgA nephropathy.
* Primitive and secondary forms can be included
* Regardless of the date of diagnosis and the level of kidney function
* With or without past of kidney transplantation
* Followed in the Nephrology Department, Strasbourg University Hospital
* Signed informed consent

Exclusion Criteria

* Active or recent infectious or inflammatory syndrome (\<2 months), recent vaccination (\<2 months), ongoing acute humoral rejection treatment, treatment with plasma exchanges (\<2 months), current treatment with complement inhibitors
* Impossibility of giving informed information (emergency situation, difficulties in understanding, etc.)
* Subject under safeguard of justice, guardianship or curatorship
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service de néphrologie

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Sophie Ohlmann- Caillard, MD

Role: CONTACT

03.88.11.67.68

Facility Contacts

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Sophie Caillard, MD

Role: primary

Other Identifiers

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8361

Identifier Type: -

Identifier Source: org_study_id

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